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FDA 510(k)

ROOT CANAL KIT

K-Number: K811023 · 1981-05-05

ApplicantDentsply Intl.
Decision Date1981-05-05
Product CodeELC
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ROOT CANAL KIT is the device name listed in this FDA 510(k) record. The listed applicant is Dentsply Intl.. It received FDA 510(k) clearance on 1981-05-05 under 510(k) number K811023. The device is classified under product code ELC. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ROOT CANAL KIT?

ROOT CANAL KIT is a medical device that received FDA 510(k) clearance on 1981-05-05. The listed applicant is Dentsply Intl.. The 510(k) number is K811023.

When did ROOT CANAL KIT receive FDA 510(k) clearance?

ROOT CANAL KIT received FDA 510(k) clearance on 1981-05-05, under 510(k) number K811023.

Who is the listed applicant for ROOT CANAL KIT?

The FDA 510(k) record lists Dentsply Intl. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ROOT CANAL KIT?

The FDA product code for ROOT CANAL KIT is ELC.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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